Director, Regulatory Affairs & Compliance

About Women’s Health

Bonafide, Uqora and Equelle comprise Pharmavite's Women's Health portfolio. Collectively, these brands are driven by their promise to champion women's health and joy at every age.

Our People

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Our Women’s Health team is composed of highly experienced professionals dedicated to making a meaningful impact. Bring your whole self to our Women’s Health brands — you’ll be welcomed by a team that shares your passion, purpose, and pride in our products while embracing your unique talents, creativity, and collaborative spirit.

This role is not available for any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT.

Position Summary

The Director, Regulatory Affairs & Compliance provides strategic leadership and oversight of regulatory and compliance activities across the company's product portfolio. This role is responsible for ensuring that existing and new products, ingredients, labeling, claims, and supporting documentation comply with applicable FDA statutes, regulations, and guidance. In partnership with Legal Affairs, the Director also supports compliance with applicable FTC requirements and guidance related to product claims, advertising, and substantiation.

Key Responsibilities

* Oversee corporate regulatory requirements for the Women's Health business. * Oversee regulatory compliance across dietary supplements, cosmetics, medical devices, and OTC drug products. * Provide regulatory support and strategic guidance to project teams. * Prepare FDA regulatory submissions, including but not limited to, structure/function claims notifications, GRAS documentation, NDIN submissions, and related technical files. * Provide strategic direction and guidance for dietary supplements, including proactive willingness to engage, learn, and work with outside experts in other categories including medical devices, cosmetics, and OTC drugs. * Apply existing and new FDA regulatory requirements as they relate to company products, procedures, scientific research, and record keeping. * Provide advice regarding potential and existing claims for products (all types), including providing input on possible interpretations and implications of claims, label design and label architecture. * Keep apprised of and assess the impact of new and proposed changes in laws, rulings, regulations and enforcement activities that may affect the use of ingredients, product safety, labeling, advertising, or claims. * Act as a direct liaison with the FDA regarding required submissions to FDA. Respond to FDA requests related to regulatory submissions and other matters, as appropriate. Actively participate in regulatory committees and other relevant trade association groups and serve as the regulatory voice of the company with respect to ingredients, products, and claims. *

Qualifications

* Bachelors Degree or equivalent work experience Nutritional, physical, of life sciences * Advanced Degree or equivalent work experience * 7-9 years related experience Broad Regulatory management and strategic development * 7-9 years related experience Dietary supplements * 4-6 years related experience Direct interaction with the FDA Regulatory Affairs Certifications (RAC)-RAPS Upon Hire *

Knowledge, Skills & Competencies

* Comprehensive knowledge of laws and regulations in an FDA regulated environment * Knowledge of nutrition and health sciences * Verbal, written, and presentation skills * Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and team building * Strong strategic thinker with deep business acumen and business analytical skills * Ability to work alone or as part of a team and willingness to “role up sleeves” and do the work * Demonstrated ability working in a deadline-driven environment and handling multiple concurrent assignments and meeting deadlines Meticulous attention to detail *

Physical or Work Requirements

Primarily performs work in an office or remote environment and require extended periods of sitting, computer use, and verbal communication. Physical activity is generally limited to occasional standing, walking, repetitive keyboard and mouse use, and light lifting of office materials or equipment up to 10–15 pounds. Employees may occasionally travel or attend meetings in varying office or customer environments.

Travel

10% Occasional travel is required for business and industry meetings.

OUR OFFER

Here, career paths aren't predefined, and bureaucratic limitations don't exist - you have the opportunity to grow, learn from industry pioneers, and develop the way you want to. Our Women's Health brands are investing more in the development of our team - to help us deliver on our purpose and help you achieve your career aspirations. Our environment is geared to fuel curiosity, encourage experimentation, and generate learning as this is the way we develop ourselves and our organization. We are committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being - as well as peace of mind. These rewards - plus our new recognition program - ensure employees feel supported both at work and home.

OUR OFFER

Here, career paths aren't predefined, and bureaucratic limitations don't exist - you have the opportunity to grow, learn from industry pioneers, and develop the way you want to. Our Women's Health brands are investing more in the development of our team - to help us deliver on our purpose and help you achieve your career aspirations. Our environment is geared to fuel curiosity, encourage experimentation, and generate learning as this is the way we develop ourselves and our organization. We are committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being - as well as peace of mind. These rewards - plus our new recognition program - ensure employees feel supported both at work and home.

National Target Base Pay Range: (min) $143,000 - (mid) $191,000 - (max) $239,000 . The salary range for this position is based on national standards.

For candidates in California and New York metro the Target Base Pay Range is (min) $159,000 - (mid) $212,000 - (max) $265,000 to reflect the cost of living and market conditions in those areas.

This represents the minimum and maximum base salary range for this role, plus annual incentive. Various elements are used to determine a candidate’s starting salary such as job experience, specific skills, and comparison to internal incumbents currently in the role. This information is provided to applicants in accordance with state and local laws. Bonafide is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. Bonafide recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities. Bonafide also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email recruiter@pharmavite.com.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications of employees assigned to this job.

CALIFORNIA FAIR CHANCE ACT

Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

JOB ALERT FRAUD

We have become aware of scams from individuals, organizations, and internet sites claiming to represent Bonafide in recruitment activities in return for disclosing financial information. Our hiring process does not include text-based conversations or interviews and never requires payment or fees from job applicants. All of our career opportunities are regularly published and updated on Bonafide’s Careers section. If you have already provided your personal information, please report it to your local authorities. Any fraudulent activity should be reported to: recruiter@pharm avite.com.

DISCLOSURE

Any misrepresentations or false statements during the application process, including regarding U.S. work authorization and/or the need for immigration sponsorship or support, may result in the rejection of candidacy or the termination of employment.

This represents the minimum and maximum base salary range for this role, plus annual incentive. Various elements are used to determine a candidate’s starting salary such as job experience, specific skills, and comparison to internal incumbents currently in the role. This information is provided to applicants in accordance with state and local laws.

Bonafide is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. Bonafide recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities.

Bonafide also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email recruiter@pharmavite.com .

*Disclaimer*

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications of employees assigned to this job.

CALIFORNIA FAIR CHANCE ACT

Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

JOB ALERT FRAUD

We have become aware of scams from individuals, organizations, and internet sites claiming to represent Bonafide in recruitment activities in return for disclosing financial information.

Our hiring process does not include text-based conversations or interviews and never requires payment or fees from job applicants. All of our career opportunities are regularly published and updated on Bonafide’s Careers section.

If you have already provided your personal information, please report it to your local authorities. Any fraudulent activity should be reported to: recruiter@pharmavite.com .

DISCLOSURE

Any misrepresentations or false statements during the application process, including regarding U.S. work authorization and/or the need for immigration sponsorship or support, may result in the rejection of candidacy or the termination of employment.